Nivolumab denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for immunotherapy. In this case, the patient has a history of metastatic kidney cancer which has spread to the right knee, and also a history of lupus vasculitis. It is not clear if the patient has clear cell or non-clear cell kidney cancer. However, both have immunotherapy treatment options including nivolumab and ipilimumab, pembrolizumab, or in combination with tyrosine kinase inhibitors. In patients with systemic lupus erythematosus complicated by vasculitis, the use of immunotherapy carries a significant risk of triggering disease flares or severe autoimmune complications. As such, immunotherapy is used with extreme caution in these patients, balancing cancer treatment benefits against the risk of autoimmune exacerbation.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Nivolumab (Opdivo) injections (CPT code J9299) 292.5 mg intravenous (IV) every 14 days for six cycles. The patient is not eligible for U.S. Food and Drug Administration (FDA) standard approved use of Opdivo, as he has microsatellite stable disease (Smith and Desai). The FDA supports treatment with Opdivo for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that “has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.” This patient has the standard care option of regorafenib for treatment of microsatellite stable disease. The recommendation for the combination of regorafenib with Opdivo is based on recent data from the phase 1b results of the REGONIVO trial.

Nature of Statutory Criteria/Case Summary: The parent of a male enrollee has requested authorization and coverage for immunotherapy with nivolumab (Opdivo). The Health Plan has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee’s grade IV glioblastoma. Although multiple trials are testing various forms of immunotherapy in patients with glioblastoma, published data remain limited. In a phase I trial investigating the safety of monotherapy or combination therapy with two checkpoint inhibitors, 40 patients received either Opdivo with or without ipilimumab. Overall, monotherapy with Opdivo was better tolerated than combination therapy. However, the authors concluded that further studies are needed to help select patients most likely to respond to checkpoint inhibitor immunotherapy.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Nivolumab, then check the rights and deadlines that apply to your plan.